Exelixis, Inc. (NASDAQ:EXEL) announced the company has initiated submission of its rolling New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for cabozantinib for the treatment of advanced renal cell carcinoma (RCC) patients who have received one prior therapy. Cabozantinib was granted Breakthrough Therapy Designation by the FDA in August 2015. Exelixis agreed with FDA that the submission would be a rolling NDA and the company has filed the first component of the application for potential approval of cabozantinib in the United States. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Exelixis plans to complete the NDA submission before the end of 2015.
The rolling NDA submission is based on results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival (PFS); compared with everolimus, cabozantinib was associated with a 42% reduction in the risk of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.
“New treatment options are urgently needed for patients with advanced renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. “The initiation of the NDA submission process for cabozantinib marks an important step forward in our efforts to make a meaningful difference in the lives of people with advanced kidney cancer, and we look forward to working closely with the FDA towards the goal of making cabozantinib available to these patients and their physicians as soon as possible.”
Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ®in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway,Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the NDA for advanced RCC. (Original Source)
Shares of Exelixis closed yesterday at $5.49. EXEL has a 1-year high of $6.81 and a 1-year low of $1.26. The stock’s 50-day moving average is $5.89 and its 200-day moving average is $4.52.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on September 28, Cowen analyst Eric Schmidt reiterated a Buy rating on EXEL. Separately, on September 18, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and John Sonnier have a total average return of 30.1% and 14.5% respectively. Schmidt has a success rate of 54.1% and is ranked #55 out of 3795 analysts, while Sonnier has a success rate of 56.5% and is ranked #428.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.